Treatment persistence (continuing to take medication for the prescribed period) and treatment adherence (complying with the prescription in terms of drug schedules and dosage) are both important when treating chronic diseases such as type 2 diabetes (T2D). They can be indicators of patient satisfaction with treatment. In T2D, the achievement of optimal outcomes requires both persistence with and adherence to prescribed therapy. Poor persistence with and adherence to T2D medication can have profound consequences for the patient, including non-achievement of glycaemic goals and an increased risk of long-term complications and mortality. Therefore, poor treatment persistence and adherence may also have economic consequences, including increased healthcare resource utilization and healthcare costs. Treatment persistence and adherence are affected by several factors, including the mode of administration, administration frequency/regimen complexity, and patient expectations. The aims of this review are as follows: to provide an overview of persistence with and adherence to different antidiabetes therapies for patients with T2D in the real-world setting; examine factors contributing to poor treatment persistence and adherence; and assess available data on the impact of poor treatment persistence and/or adherence on clinical and economic outcomes. Numerous potential targets for improving treatment persistence and/or adherence are identified, including developing less complex treatment regimens with lower pill burdens or less frequent injections, improving the convenience of drug-delivery systems, such as the use of insulin pen devices rather than the conventional vial and syringe, and developing therapies with an improved safety profile to alleviate patient fears of adverse effects, such as weight gain and risk of hypoglycaemia. Funding : Sanofi.

Objective The objective of this study was to assess the validity of the Cornerstone Diabetes Simulation (CDS), a Microsoft Excel ®-based patient-level simulation for type 2 diabetes mellitus based on risk equations from the revised United Kingdom Prospective Diabetes Study Outcomes Model (UKPDS-OM2, also known as UKPDS 82). Methods Three levels of validation were conducted. Internal validation was assessed through independent review and model stress-testing. External validation was addressed by populating the CDS with baseline characteristics and treatment effects from three major diabetes clinical trials used in the Fifth Mount Hood Diabetes Challenge (MH5) for computer simulation models. Cross-validation of predicted outcomes was tested versus eight models that participated in the MH5. Simulated results were compared with observed clinical outcomes via the coefficient of determination (R 2) for both the absolute risk of each clinical outcome and the difference in absolute risk between control and intervention arm in each trial. We ensured transparency of all model inputs and assumptions in reporting. Results The CDS could be used to predict 18 of 39 single and composite endpoints across the three trials. The model obtained an R 2 of 0.637 for predicted versus observed absolute risks, and an R 2 of 0.442 for predicted versus observed risk differences between control and intervention. Among the other eight models, only one obtained a higher R 2 value under both definitions, albeit based on only four predicted endpoints. Conclusions The CDS provides good predictions of diabetes-related complications when compared to observed trial outcomes and previously validated models. The model has value as a validated tool in cost-effectiveness evaluations.

AimTo evaluate the effect of delaying treatment intensification with a glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) on clinical and economic outcomes in patients with type 2 diabetes (T2D).MethodsWe conducted a retrospective observational claims study using IMPACT (Impact National Managed Care Benchmark Database) in adult patients with T2D who initiated basal insulin between January 1, 2005 and December 31, 2012, with or without OADs, who remained uncontrolled (glycated haemoglobin [HbA1c] ≥7.0%). Patients were categorized into 3 groups: early, delayed, and no intensification with a GLP‐1 RA. We evaluated changes from baseline to follow‐up at 12 months for HbA1c level, rate of hypoglycaemic events, and healthcare costs, and we assessed the association between baseline patient characteristics and subsequent treatment intensification.ResultsA total of 139 patients (9.0% of 1552 eligible patients) met criteria for inclusion in the early intensification group, 588 patients (37.9%) met criteria for inclusion in the delayed intensification group, and 825 patients (53.2%) met criteria for inclusion in the no intensification group. Mean baseline HbA1c values were 9.16%, 9.07%, and 9.34%, respectively. At follow‐up, delayed intensification was associated with significantly smaller decreases in HbA1c from baseline (−0.68%) compared with early intensification (−1.01%). Rates of overall hypoglycaemia were numerically greater in the delayed intensification group than in the early intensification group (0.26 vs 0.06 events/patient‐years of exposure, respectively). Change in semi‐annual total healthcare costs was greater in the no intensification group (+5266 USD) compared with the early intensification group (−560 USD) and the delayed intensification group (+1943 USD).ConclusionsTimely addition of a GLP‐1 RA to therapy for patients with T2D who were not adequately controlled with basal insulin is associated with better clinical and economic outcomes.

Introduction: Many patients with type 2 diabetes mellitus (DM) fail to achieve glycaemic control despite recommended treatment strategies to reduce glycated haemoglobin (HbA1c). This real-world retrospective cohort study compared HbA1c change and treatment patterns between those intensifying and not intensifying therapy with oral antidiabetic drugs (OADs). Materials and methods:Patients suboptimally controlled on OADs (>58 mmol/mol [>7.5%] or >64 mmol/mol [>8.0%] for high risk, index 1) were included from IQVIA Medical Research Data. Intensifiers within 12 months of index 1 were matched (1:1) to nonintensifiers. Primary outcomes were HbA1c change and proportion of participants achieving HbA1c targets 6 and 12 months post-index 2 (date of intensification [intensifiers] or pseudodate [nonintensifiers]). Therapy adherence was also assessed.Results: A total of 10 832 participants (5539 intensifiers and 5293 nonintensifiers) were included. Mean HbA1c decrease from baseline to 6 months was −1.13% (intensifiers) vs −0.75% (nonintensifiers), with no substantial further change at 12 months. Cox proportional hazards (PH) analysis suggested a nearly 20% greater chance of target achievement at 6 months for intensifiers vs nonintensifiers (hazard ratio [HR]: 0.79 [95% confidence interval [CI]: 0.73-0.86]), which was similar at 12 months (HR: 0.80 [95% CI: 0.74-0.86]). Intensifiers tended towards greater adherence to baseline therapy (90% [standard deviation (SD): 14.9] vs nonintensifiers 87% [SD: 16.0]), which decreased following intensification.Conclusions: Significant reductions in HbA1c were evident at 6 months and were greater in intensifiers vs nonintensifiers. Little additional clinical benefit was seen 12 months postintensification. Despite good treatment adherence, many participants failed to achieve target HbA1c; actions beyond improved adherence are needed to improve suboptimal HbA1c.

IntroductionTreatment guidelines recommend a stepwise approach to glycemia management in patients with type 2 diabetes (T2D), but this may result in uncontrolled glycated hemoglobin A1c (HbA1c) between steps. This retrospective analysis compared clinical and economic outcomes among patients with uncontrolled T2D initiating two oral antidiabetes drugs (OADs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or basal insulin in a real-world setting.MethodsAdults with T2D on OAD monotherapy were identified in the MarketScan claims database (2007–2014). Those initiating two OADs (simultaneously or sequentially), GLP-1 RAs, or basal insulin were selected (date of initiation was termed the ‘index date’); patients were required to have HbA1c > 7.0% in the 6 months pre-index date. HbA1c was compared from 6 months pre- to 1-year post-index. Annual all-cause healthcare utilization and costs were reported over the 1-year follow-up period.ResultsData for 6054 patients were analyzed (2-OAD, n = 4442; GLP-1 RA, n = 361; basal insulin, n = 1251). Baseline HbA1c was high in all cohorts, but highest in the basal-insulin cohort. Treatment initiation resulted in reductions in HbA1c in all cohorts, which was generally maintained throughout the follow-up period. Average HbA1c reductions from the 6 months pre- to 1 year post-index date were −1.2% for GLP-1 RA, −1.6% for OADs, and −1.8% for basal insulin. HbA1c < 7.0% at 1 year occurred in 32.6%, 47.5%, and 41.1% of patients, respectively. Annual healthcare costs (mean [SD]) were lowest for OAD (US$10,074 [$22,276]) followed by GLP-1 RA (US$14,052 [$23,829]) and basal insulin (US$18,813 [$37,332]).ConclusionDespite robust HbA1c lowering following treatment initiation, many patients did not achieve HbA1c < 7.0%. Basal insulin, generally prescribed for patients with high baseline HbA1c, was associated with a large reduction in HbA1c and with higher costs. Therapy intensification at an appropriate time could lead to clinical and economic benefits and should be investigated further.FundingSanofi U.S., Inc.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0429-x) contains supplementary material, which is available to authorized users.